clinical trial · NCT06241456
FT825/ONO-8250, an Off-the-Shelf, HER2 CAR-T, With or Without Monoclonal Antibodies in Advanced Solid Tumors
Advanced Solid TumorFT825FludarabineCyclophosphamideBendamustineDocetaxelCisplatinCetuximab
brief summary
This is a phase 1 study designed to evaluate the safety, tolerability, and antitumor activity of FT825 (also known as ONO-8250) with or without monoclonal antibody therapy following chemotherapy in participants with advanced human epidermal growth factor receptor 2 (HER2)-positive or other advanced solid tumors. The study will consist of a dose-escalation stage, followed by an expansion stage to further evaluate the safety and activity of FT825 in indication-specific cohorts.
started
Jan 5, 2024
primary completion
May 1, 2029
completion
May 1, 2044
last updated
Dec 9, 2025
official title
A Phase 1 Study of FT825/ONO-8250, an Off-the-Shelf CAR T-Cell Therapy, With or Without Monoclonal Antibodies, in HER2-Positive or Other Advanced Solid Tumors
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol